'What Do We Know About the Pink Flame Retardants Used to Slow the Los Angeles Fires?'

 Aircraft battling fires raging through the Los Angeles area are dropping more than water: Hundreds of thousands of gallons of hot-pink fire suppressant ahead of the flames in a desperate effort to stop them before they destroy more neighborhoods.

The fires have killed at least 24 peopleopens in a new tab or window, displaced thousandsopens in a new tab or window, and destroyed more than 12,000 structures since they began last Tuesday. Four fires driven by strong Santa Ana windsopens in a new tab or window have charred about 62 square miles (160 square kilometers), according to Cal Fire.

Fire agencies said the suppressants -- most often used to fight forest fires -- are an invaluable tool. But what is in them and are they safe?

Here's what to know:

Why Are They Being Used in Los Angeles?

The fires are burning quickly through canyons and other rugged areas that are difficult for firefighters on the ground to reach, Cal Fire said.

While fire suppressants can be very effective, they do have limitations, the agency said: Strong winds can make it too dangerous to fly at the low altitudes needed for drops and can dissipate the retardant before it hits the ground.

Besides Cal Fire, multiple agencies have dropped fire retardant and water, including the U.S. Forest Service, the Los Angeles and Ventura county fire departments, the city, and the National Guard.

How Do They Work?

Aerial fire suppressants are generally a mixture of water, ammonium phosphate -- essentially fertilizer -- and iron oxide, which is added to make the retardant visible, said Daniel McCurry, PhD, a civil and environmental engineering professor at the University of Southern California (USC).

The Forest Service, which has used 13 aircraft to dump suppressants on the Los Angeles fires, said they help starve a fire of oxygen and slow the rate of burn by cooling and coating vegetation and other surfaces.

Perimeter, the company that supplies fire retardant to the Forest Service and other agencies, said the phosphate changes the way cellulose in plants decomposes and makes them non-flammable.

Potential Effects on Environment and Wildlife

The fire suppressants are generally considered safe for people, but many worry about their potential effects on wildlife.

The Forest Service bans use of aerial suppressants over waterways and endangered species habitats, "except when human life or public safety are threatened," due to potential health effects on fish and other wildlife.

McCurry said he and other researchers tested several suppressants and found heavy metals, including chromium and cadmium, in one commonly used by the U.S. Forest Service.

McCurry said the study's findings suggest that it's "plausible" that fire suppressants could contribute to spikes of chromium and other heavy metals in waterways downstream of wildfires.

"We don't quite have a smoking gun yet because it's difficult, although not impossible, to prove where a heavy metal came from," McCurry said. "We're working on that."

Perimeter said McCurry's research was on a formulation that wasn't used in California and is no longer used by the Forest Service. The company also said it doesn't add metals, which it says are naturally present in all ammonium phosphate fertilizers, and that its aerial suppressants "are exhaustively tested by the USDA Forest Service and meet or exceed all health and safety standards."

Use of Retardants Seen as Imperative to Avoid Greater Risks

The use of fire retardants is imperative to putting out wildfires that expose millions of people to health risks, including from a toxic mix of microscopic particles that can cause breathing and heart problems by penetrating deep into the lungs and bloodstream.

Studies have shown that wildfire smokeopens in a new tab or window accounted for up to half of all health-damaging particle air pollution in the western U.S. in recent years as warming temperatures fueled more destructive blazes.

And research released last yearopens in a new tab or window by the Alzheimer's Association found that wildfire smoke may be worse for brain health than other types of air pollution, raising the risk of dementia.

"The use of wildland fire retardant is the best way to save lives, protect communities, and keep fires small," said Edward Goldberg, vice chairman of solutions at Perimeter.

McCurry, the USC researcher, said more study is needed on fire suppressants -- including in Los Angeles once the fires are out -- but he understands their value: "If there was a brush fire coming for my house, I'd still rather [have that] than paint a lot of [fire retardant] in front of it."

https://www.medpagetoday.com/publichealthpolicy/environmentalhealth/113767

Top 10 Signs of Diabetes You Can See

 

Internal medicine and rheumatology specialist Siobhan Deshauer, MD, goes over the visual physical signs that a patient might have diabetes.

Following is a partial transcript of the video (note that errors are possible):

Deshauer: Today, we're breaking down the subtle signs of undiagnosed diabetes, signs you may be able to spot on yourself. But why should you care? Well, 1 in 4 American adults with diabetes are completely unaware they have it. If we catch it early, we can prevent all of the issues we're about to discuss. By the end of this video, you'll know exactly what to look out for so you can take charge of your health.

Okay. What is diabetes? Simply put, diabetes is a condition where your body has trouble managing blood sugar levels. Normally, a hormone called insulin moves sugar from your blood into your cells where it can be used for energy. But when you have diabetes, either your pancreas stops making insulin, which we call type 1 diabetes, or your cells become resistant to insulin and stop responding properly, which we call type 2 diabetes. In both cases, sugar builds up in your blood over time and this causes irreversible damage to your blood vessels, nerves, and organs. Since type 2 diabetes is far more common, that's what we're going to focus on in this video.

All right. Let's get into the symptoms. One of the most common signs of diabetes is frequent urination, also known as polyuria. Patients tell me this is most noticeable at night when they are suddenly waking up multiple times a night to go to the bathroom. This happens because as blood sugar levels rise, your kidneys have to work harder to filter and absorb that excess glucose. At a certain point, they can't keep up and excess glucose spills out into your urine, dragging water with it. This not only leads to increased urination, but also a state of dehydration and increased thirst. It's a vicious cycle, pee more, drink more. As you can imagine, trying to hydrate with sugary drinks like juice or pop just makes this worse.

Okay. Now, grab a mirror because we're going to focus on some signs of diabetes that you can see on your skin. First up, acanthosis nigricans. This is a skin condition characterized by dark, velvety patches that you can usually find on the back of the neck, armpit, or groin. Most of the time when you see this it's a sign of insulin resistance. Basically, your cells stop responding to normal insulin levels, so your pancreas responds by producing even more insulin. When insulin levels rise, they activate insulin-like growth factor receptors in the skin. This stimulates the growth of skin cells like keratinocytes and fibroblasts, particularly in areas with high friction, like the armpits. That's what causes the thickening and hyperpigmentation of the skin. If you notice these changes, it could be an early warning sign of diabetes.

Here's another sign to look out for: skin tags. Just like acanthosis nigricans, these little skin flaps can show up in areas of friction where skin folds together, like the neck, armpits, and groin. While they're usually harmless, having multiple skin tags can be a sign of insulin resistance.

All right. Now, let's talk about infections. Diabetes can create the perfect environment for bacteria and fungi to thrive because high blood sugar levels literally feeds these little organisms, helping them grow and spread. Plus, consistently high sugar levels significantly weakens your immune system. This can show up on the skin as abscesses or yeast infections, but it doesn't stop there. Remember how excess glucose can spill out into the urine? Well, that's one reason that people with diabetes are far more likely to develop urinary tract infections. And yes, that affects both men and women.

Did you know that high blood glucose can literally cause your tendons to become coated in sugar? So what would that feel like? Let's start with a quick test. Put your hands together like you're about to pray. This is normal. But if your fingers can't fully straighten or your palms aren't touching, this is abnormal and it's called a positive prayer sign. This can be caused by diabetic cheiroarthropathy, also known as diabetic stiff hand syndrome, and it's directly related to high blood sugar. Excess sugar actually binds to the proteins in your skin and tendons in a process called glycosylation. Remember this term because we're going to talk about it more later. The sugar-coated soft tissues in your hand become thick and less flexible, which limits the range of movement. On a few occasions, I have actually seen this mistaken for arthritis.

Let's take a look at this published case report. A 52-year-old woman came into the office with pain and stiffness in her hands. This is the x-ray of her hands. Her joints look totally normal with no sign of arthritis. Although her joints were fine, the pain and stiffness was coming from the sugar-coating of her tendons and soft tissue of the hand.

Another common issue that can be triggered by diabetes is called trigger finger. It occurs when one of the tendons that bends your finger gets inflamed. Patients will often come in with their finger stuck in this position and then when they try to extend it, it sort of snaps into place. The condition got its name from that unmistakable snapping sensation. Once again, this is caused by glycosylation of the tendon, this time impairing the tendon from gliding smoothly.

When I'm examining a patient with trigger finger, I can usually feel a lump at that level of the first crease of the finger. That's the A1 pulley, and that's usually where the tendon is getting caught. I'll typically treat it with a steroid injection to decrease the inflammation around the tendon. But in some cases, that doesn't work and it requires surgery to get that tendon moving smoothly again. Something similar can happen to the shoulder called adhesive capsulitis, or frozen shoulder, and that can cause a tremendous amount of pain and stiffness, which can last for years.

But beyond joints and tendons, diabetes can seriously impact your nerves. High sugar levels are toxic to the nerves themselves and also to the tiny blood vessels that supply nutrients and oxygen to the nerves. As the nerves become damaged, you might experience numbness, tingling, or pain, particularly in the hands and feet. This is known as neuropathy.

Watch the video above for more.

Siobhan Deshauer, MD, is an internal medicine and rheumatology specialist in Toronto. Before medicine, she was a violinist, which is why her YouTube channelopens in a new tab or window is called Violin MD.

https://www.medpagetoday.com/popmedicine/popmedicine/113711

ND 1st state to cover Ozempic under the ACA

 North Dakota has become the first state to cover weight loss drugs under the ACA for diabetes and obesity.

As of Jan. 1, individual ACA plans and small-group plans from employers in the state include coverage for GLP-1s and gastric inhibitory polypeptide drugs, according to the North Dakota Insurance Department. 

CMS approved the changes to the state's essential health benefit benchmark plan in 2023, which also includes added coverage for insulin and insulin supplies, hearing aids, periodontal disease and PET scans for prostate cancer.

North Dakota Insurance Commissioner Jon Godfread told The Forum the state is the first to cover GLP-1s through the ACA, and others are expected to follow. 

Blue Cross Blue Shield of North Dakota also began offering coverage for weight loss medications for individual and small group plans on Jan. 1, a company spokesperson told the outlet.

The financial strain caused by expensive GLP-1 drugs has been evident in insurers' financial reports throughout the last few years, with some large group plans and self-funded employers dropping coverage.

According to a Mercer survey of more than 2,000 employers in 2024, 44% with 500 or more employees offer GLP-1 coverage for obesity. Among employers with 20,000 or more employees, 64% offer coverage.

The Biden administration has also proposed expanding Medicare and Medicaid coverage for weight loss drugs, with some state Medicaid programs already providing coverage.

https://www.beckerspayer.com/payer/the-first-state-to-cover-ozempic-under-the-aca.html

FDA sets August date for subcutaneous Leqembi decision

 The FDA has started its review of a subcutaneous injection formulation of Eisai and Biogen's Alzheimer's drug Leqembi that could allow patients to receive maintenance doses at home, rather than in an infusion clinic.

Eisai and Biogen's filing is for a once-weekly autoinjector formulation of Leqembi (lecanemab) that would be used after a biweekly IV initial induction course, the duration of which remains under discussion with the FDA. The US regulator expects to complete its review by 31st August.

It is part of a concerted effort by the two pharma groups to simplify the dosing regimen for the anti-amyloid drug and try to accelerate sales growth, which has remained stubbornly sluggish since it was approved in 2023.

Globally, the drug made $67 million in the third quarter of 2024, including $39 million in the US – which actually came in a little ahead of analyst expectations – but regulatory rejections in Europe and Australia, as well as negative reimbursement decisions by health technology assessment (HTA) bodies, have dialled back forecasts.

The FDA filing for the autoinjector version is based on data from the Clarity AD open-label extension (OLE), which showed that, after induction, six months of weekly dosing of subcutaneous Leqembi was superior to biweekly infusions at removing amyloid plaques from the brains of Alzheimer's patients.

In tandem, Eisai and Biogen have also filed to extend the label for Leqembi to include a maintenance dosing regimen that would reduce the number of intravenous infusions needed to prevent amyloid accumulation in the brain to one per month. A decision on that application is due by 25th January.

If approved, the two extensions to the Leqembi product range could also help Eisai and Biogen ward off competition from Eli Lilly, those rival anti-amyloid therapy Kisunla (donanemab), which got full FDA approval last summer.

Lilly claimed at launch that its drug has advantages over Leqembi, including approval for use only until amyloid plaques are cleared from the brain, while Eisai and Biogen's label calls for continuous treatment, and also offers a once-monthly dosing schedule that requires fewer visits to infusion clinics.

If the autoinjector is approved, Leqembi will be the only treatment for Alzheimer's that can be administered subcutaneously at home, with the dosing process taking around 15 seconds versus approximately an hour for the current infusion regimen.

To date, Leqembi has been approved in the US, Japan, China, South Korea, Hong Kong, Israel, UAE, GB, Mexico, and Macau, and in November was backed for approval in the EU, reversing an earlier negative decision.

Analysts at Jefferies have previously suggested that the subcutaneous formulation will be the key to kickstarting sales growth, allowing Eisai and Biogen to build on steady growth in the US, even with the drawbacks associated with IV administration.

https://pharmaphorum.com/news/fda-sets-august-date-subcutaneous-leqembi-decision

Bayer gains ground in two-fronted Parkinson's offensive

 Bayer is preparing to start a phase 3 trial of its cell therapy candidate bemdaneprocel for Parkinson's disease after discussing phase 1 results with the FDA, while its experimental gene therapy is also advancing into a phase 2 study.

According to Bayer's BlueRock Therapeutics subsidiary – which is running the exPDite-2 trial of bemdaneprocel due to get underway in the first half of this year – it will be the first phase 3 study of an allogeneic pluripotent stem cell-based therapy to treat Parkinson's.

Bemdaneprocel is administered by surgical transplantation into a part of the brain known as the putamen, in the hope of grafting dopamine-producing cells that can bolster levels of the neurotransmitter, which is depleted in Parkinson's patients. The study will compare the cell therapy to a sham surgical procedure.

The move into phase 3 follows positive 24-month data from the phase 1 exPDite study in 12 patients, reported last September, which backed up the safety and tolerability of the therapy and showed that the transplanted cells were surviving and growing in the brain.

Moreover, the results also revealed trends towards improvement in motor function assessed using the MDS-UPDRS Part II and III scales and the Hauser PD Diary.

exPDite-2 will enrol a target of 102 patients with moderate Parkinson's symptoms, measuring the change from baseline to week 78 in Hauser PD Diary measure of 'on' time without dyskinesia – in other words, the period where muscle symptoms associated with Parkinson's are controlled without involuntary, uncontrolled movements.

The FDA awarded bemdaneprocel a regenerative medicine advanced therapy (RMAT) designation last year, which can accelerate the development of new treatments by offering increased flexibility in clinical trials, early FDA engagement, and priority review.

First patient randomised in gene therapy trial

Meanwhile, another Bayer subsidiary – AskBio – has started randomising the first patients in its phase 2 trial of AB-1005 (AAV2-GDNF), which delivers a gene into the putamen region of the brain that expresses a growth factor called GDNF that is thought to promote the survival of dopaminergic neurons.

The start of a phase 2 REGENERATE-PD study follows 36-month results from a phase 1b trial of AB-1005, reported last year, which demonstrated a favourable safety profile and continued positive trends in assessed clinical measures of AB-1005 with no associated serious adverse events.

Once again, there were trends towards improved MDS-UPDRS and diary scores, along with signs that patients needed lower levels of the standard Parkinson's medication levodopa to control motor symptoms.

AskBio is also exploring AB-1005 beyond Parkinson's and is currently enrolling participants in the US with the Parkinsonian subtype of multiple system atrophy (MSA-P) into a phase 1 trial.

Bayer agreed a $600 million deal in 2019 to take full control of BlueRock, which was formed in 2016 as a joint venture between the drugmaker's Leaps by Bayer venture capital group and private equity firm Versant.

It followed that deal with a $4 billion agreement to acquire AskBio a year later, cementing its ambition in the regenerative medicines category. Bayer has said it wants both companies to operate independently in order to preserve their entrepreneurial culture.

https://pharmaphorum.com/news/bayer-gains-ground-two-fronted-parkinsons-offensive

Republicans Rally Behind Hegseth, Paving Path for Confirmation

 

• Democrats tore into Pentagon pick’s character, experience
• He dismissed allegations about his past as ‘anonymous smears’

Pete Hegseth, President-elect Donald Trump’s pick to lead the Pentagon, appeared on course to win confirmation after a half-day Senate hearing, even after he was hit with hard questions from Democrats over alleged character flaws.

Republicans on the Senate Armed Services Committee, including its chairman, Roger Wicker of Mississippi, rallied around Hegseth, who dismissed accusations of past alcohol abuse, sexual misconduct and financial mismanagement of veterans groups that he led as “anonymous smears.”

https://www.bloomberg.com/news/articles/2025-01-14/republicans-rally-behind-hegseth-paving-path-for-confirmation

TG prelims beat views

 Preliminary U.S. BRIUMVI fourth quarter and full year 2024 net product revenue of $103.6 million and $310 million, respectively

Full Year 2025 target total global revenue of approximately $540 million, including BRIUMVI U.S. net product revenue of approximately $525 million

https://www.globenewswire.com/news-release/2025/01/14/3009177/8790/en/TG-Therapeutics-Provides-Preliminary-Fourth-Quarter-and-Full-Year-2024-Net-Revenue-and-2025-Anticipated-Development-Milestones.html